DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The Information Disclosure Statements filed on 3/12/2024 and 6/7/2024 have been entered and considered. Initial copies of the form PTO-1449 are enclosed with this action.
Status of claims
On 5/24/2024, the applicant canceled claims 1-15, and added claims 16-35.
In summary, claims 16-35 are pending and examined in the office action.
Priority
Instant application 18602867, filed 03/12/2024, is a Continuation of 16449329, filed 06/21/2019, now U.S. Patent 11950553.
16449329 is a Continuation of PCT/EP2017/084300, filed 12/22/2017, and claims foreign priority to 2018058, filed 12/23/2016, which disclosed the claimed subject matter, thus is recognized.
Claim Objections
Claims 1 and 27 are objected for following informality:
Claim 1 (d), line 2, recites “L2 and L3-shoot meristem layer”, which contains grammar error. Since “and” is recited, it is suggested to change “layer” to –layers--.
Claim 1 (d), line 3, recites “the first and the second L-1 localized trait of interest is”, which contains grammar error.
Since “and” is recited, it is suggested to be changed to --the first and the second L-1 localized traits of interest are--.
The preamble of the claim 17 recites “an L1, L2 and L3- shoot meristem layer”, which contains grammar error. Since “and” is recited, it is suggested to change “layer” to -- layers --.
Claim 17 (d), last para, line 1, recites “the first and the second L-1 localized trait of interest is”, which contains grammar error.
Since “and” is recited, it is suggested to be changed to --the first and the second L-1 localized traits of interest are--.
See the requirement of 37 CFR 1.71(a) for “full, clear, and exact terms”.
Appropriate corrections are required.
Interpretation of the "L1-localized trait"
According to the specification (p8, 4th para), an "L1-localized trait" is to be understood herein as a "trait localized in the L1-shoot meristem layer", which is a trait that is harbored essentially within the L1-shoot meristem layer, and is determined, at least essentially, by the genotype of the L1-shoot meristem layer, possibly together with one or more environmental factors. A trait localized in the L1-shoot meristem layer is passed to a periclinal chimera plant when using an L1-shoot meristem layer having this trait for producing the periclinal chimera plant, even if the L2 and/or L3-shoot meristem layers used for producing said periclinal chimera plant lack said trait.
Accordingly, an “L1-localized trait” is harbored essentially within the L1-shoot meristem layer. In another word, an “L1-localized trait” means that the trait is essentially (but not exclusively) located in L1 layer of the periclinal plant. Since wild species and cultivar plants are not periclinal plants, thus, L1, L2, L3 have the same genotype in wild species and cultivar plants. Thus, L2 and/or L3 layers of the resultant periclinal plant may also comprise such trait(s), unavoidably.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 16-26 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Filippis et al (Using a periclinal chimera to unravel layer-specific gene expression in plants. The Plant Journal 75, 1039–1049, 2013), viewed with evidence from Bolger et al (The genome of the stress-tolerant wild tomato species Solanum pennellii. Nature genetics, p1034-1039, 2014).
Claim 16 is drawn to a periclinal chimera plant comprising a first L1-localized trait of interest and a second L1-localized trait of interest, wherein the periclinal chimera is obtainable by:
(a) crossing a wild species comprising the first L1-localized trait of interest and a cultivar comprising the second L1-localized trait of interest, wherein the wild species does not comprise the second L1-localized trait of interest and the cultivar does not comprise the first L1-localized trait of interest, wherein the first L1-localized trait and the second L1-localized trait is passed to an offspring plant after crossing;
(b) selecting a first plant comprising the first L1-localized trait of interest and the second L1-localized trait of interest from the offspring plants produced by the crossing in step (a);
(c) providing a second plant not comprising both the first L1-localized trait of interest and the second L1-localized trait of interest; and
(d) making a periclinal chimera plant comprising an L1-shoot meristem layer of the first plant and the L2 and L3- shoot meristem layer of the second plant, and wherein the first and second L1-localized trait of interest is selected from the group consisting of biotic stress resistance, abiotic stress resistance, improved seed germination, fruit color and the ability to accept pollen produced by the second plant or by the plant itself.
Note: except the” biotic stress resistance, abiotic stress resistance, improved seed germination, fruit color and the ability to accept pollen” in L1 layer, the traits in all 3 layers are generic, not specific.
The claim is a product by process claim. Determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. See MPEP 2113. See In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985), which teaches that a product-by-process claim may be properly rejectable over prior art teaching the same product produced by a different process, if the process of making the product fails to distinguish the two products.
Filippis et al teach a periclinal chimera plant from grafting a cultivar plant Solanum lycopersicum and a wild-type plant Solanum pennellii (p1039, Abstract; p1046, right col, 3rd para, “EXPERIMENTAL PROCEDURES”).
Filippis et al teach that meristem that L1 layer is from wild-type plant Solanum pennellii, and L2 and L3 layers are from cultivar plant Solanum lycopersicum. L1 layer is the outer layer, L2 and L3 layers are inner layers, for both cultivar and wild-type (p1039, Abstract; p1040, figure 1).
Filippis et al teach and demonstrated some traits of L1 layer of the periclinal chimera plant, which has green fruit color trait (p1041, figure 2, far right). Thus, the L1 layer of the periclinal chimera plant of Filippis et al comprises fruit color trait.
Filippis et al does not explicitly teach or demonstrate that L1 layer of the periclinal chimera plant comprises biotic or abiotic resistant trait. However, as analyzed above, Filippis et al teach that the L1 layer of the periclinal chimera plant is from wild-type plant Solanum pennellii (p1039, Abstract).
Bolger et al provide evidence that wild-type plant Solanum pennellii comprises genes conferring tolerance/resistance to drought stress (p1036, left col, 1st para; figure 3).
Again, wild species plants are not periclinal plants, thus, L1, L2, L3 have the same genotype in wild species plants. Thus, the L1 layer of Solanum pennellii comprises trait resistant to drought stress. Since the L1 layer Solanum pennellii is the L1 layer of the periclinal plant of Filippis et al, which comprises trait resistant to drought stress.
Thus, the L1 layer of the periclinal plant of Filippis et al comprises both a fruit color trait, and a drought resistant trait that is evidenced from Bolger et al.
Therefore, the instant L1 layer and the periclinal chimera plant are not different or not distinguishable from the L1 layer and the periclinal chimera plant of Filippis et al.
Regarding dependent claims, the drought resistant trait and the fruit trait of Filippis et al read on the limitations of claims 17-19.
The wild-type Solanum pennellii is commercial irrelevant, the cultivar Solanum lycopersicum is commercial relevant. The limitation of claim 20.
Both Solanum pennellii and Solanum lycopersicum belong to genus Solanum. The limitation of claim 21.
Solanum lycopersicum has to the ability to accept pollen. The limitation of claim 24.
Claims 22-23, 25-26 recite limitations of the steps, not the structure of the L1 layer or the periclinal chimera plant. Again, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production.
Therefore, Filippis et al anticipate the claims viewed with evidence from Bolger et al.
Claims 27-35 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Filippis et al (Using a periclinal chimera to unravel layer-specific gene expression in plants. The Plant Journal 75, 1039–1049, 2013), viewed with evidence from Bolger et al (The genome of the stress-tolerant wild tomato species Solanum pennellii. Nature genetics, p1034-1039, 2014).
Claim 27 is drawn to a periclinal chimera plant comprising an L1, L2 and L3- shoot meristem layer,
a. wherein the L1-shoot meristem layer is from a first plant comprising a first L1-localized trait of interest and a second L1-localized trait of interest,
b. wherein the first L1-localized trait of interest is from a wild species comprising the first L1-localized trait of interest and wherein the wild species does not comprise the second L1-localized trait of interest,
c. wherein the second L1-localized trait of interest is from a cultivar comprising the second L1-localized trait of interest and wherein the cultivar does not comprise the first L1- localized trait of interest,
d. wherein the L2- and L3-shoot meristem layer are from a second plant, wherein the second plant does not comprise both the first L1-localized trait of interest and the second L1- localized trait of interest, and
e. wherein the first and second L1-localized trait of interest is selected from the group consisting of biotic stress resistance, abiotic stress resistance, improved seed germination, fruit color and the ability to accept pollen produced by the second plant or by the plant itself.
Note: except the” biotic stress resistance, abiotic stress resistance, improved seed germination, fruit color and the ability to accept pollen” in L1 layer, the traits in all 3 layers are generic, not specific.
As analyzed above, Filippis et al teach a periclinal chimera plant from grafting a cultivar plant Solanum lycopersicum and a wild-type plant Solanum pennellii (p1039, Abstract; p1046, right col, 3rd para, “EXPERIMENTAL PROCEDURES”).
Filippis et al teach that meristem that L1 layer is from wild-type plant Solanum pennellii, and L2 and L3 layers are from cultivar plant Solanum lycopersicum. L1 layer is the outer layer, L2 and L3 layers are inner layers, for both cultivar and wild-type (p1039, Abstract; p1040, figure 1). Filippis et al teach and demonstrated some traits of L1 layer of the periclinal chimera plant, which has green fruit color trait (p1041, figure 2, far right). Thus, the L1 layer of the periclinal chimera plant of Filippis et al comprises fruit color trait.
Filippis et al also teach and demonstrated that some traits are the same, in cultivar plant, in wide plant, and in the periclinal chimera plant. For example, the L1 layer of cultivar plant, wide plant and periclinal chimera plant all have the same green fruit color trait (p1041, figure 2(c)). The fruit color trait is one of the recited traits. Given that the wild and cultivar plants are not periclinal, and the genes and traits are in L1, L2 and L3 layers, the trait such as green fruit color, are also the same in wild and cultivar plants, although the claim requires “the L2- and L3-shoot meristem layer are from a second plant”.
Filippis et al does not explicitly teach or demonstrate that L1 layer of the periclinal chimera plant comprises biotic or abiotic resistant trait. However, as analyzed above, Filippis et al teach that the L1 layer of the periclinal chimera plant is from wild-type plant Solanum pennellii (p1039, Abstract).
Bolger et al provide evidence that wild-type plant Solanum pennellii comprises genes conferring tolerance/resistance to drought stress (p1036, left col, 1st para; figure 3). Again, wild species plants are not periclinal plants, thus, L1, L2, L3 have the same genotype in wild species plants. Thus, the L1 layer of Solanum pennellii comprises trait resistant to drought stress. Since the L1 layer Solanum pennellii is the L1 layer of the periclinal plant of Filippis et al, which comprises trait resistant to drought stress.
Thus, the L1 layer of the periclinal plant of Filippis et al comprises both a fruit color trait, and a drought resistant trait that is evidenced from Bolger et al.
Filippis et al also meet the requirement of “the second plant (cultivar) does not comprise both the first L1-localized trait of interest and the second L1- localized trait of interest”, because Bolger et al provide evidence that the resistance trait is only in the wild pennellii not in the cultivar lycopersicum (p1034, Abstract).
Therefore, the instant L1 layer, L2 and L3 layers, and the periclinal chimera plant are not different or not distinguishable from the L1 layer and the periclinal chimera plant of Filippis et al.
Regarding dependent claims, the drought resistant trait and the fruit trait of Filippis et al read on the limitations of claims 28-30.
In Filippis et al, the wild-type Solanum pennellii is commercial irrelevant, the cultivar Solanum lycopersicum is commercial relevant. The limitation of claim 31.
Both Solanum pennellii and Solanum lycopersicum belong to genus Solanum. The limitation of claim 32.
Solanum lycopersicum has to the ability to accept pollen. The limitation of claim 33.
Solanum lycopersicum is the second plant, and a cultivar, the same species and same variety, the limitation of claim 34.
Therefore, Filippis et al anticipate the claims viewed with evidence from Bolger et al.
Double Patenting
The non-statutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A non-statutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a non-statutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 16-35 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-12 of US Patent 11950553.
The US Patent and instant application share the same inventor and same applicant Keygene N.V.
The US Patent claims:
Claim 1. A method for producing a periclinal chimera plant comprising a first L1-localized trait of interest and a second L1-localized trait of interest, the method comprising:
(a) crossing a wild species comprising the first L1-localized trait of interest and a cultivar comprising the second L1-localized trait of interest, wherein the wild species does not comprise the second L1-localized trait of interest and the cultivar does not comprise the first L1-localized trait of interest, wherein the first L1-localized trait and the second L1-localized trait is passed to an offspring plant after crossing;
(b) selecting a first plant comprising the first L1-localized trait of interest and the second L1-localized trait of interest from the offspring plants produced by the crossing in step (a);
(c) providing a second plant not comprising both the first L1-localized trait of interest and the second L1-localized trait of interest; and
(d) making a periclinal chimera plant comprising an L1-shoot meristem layer of the first plant and the L2 and L3-shoot meristem layer of the second plant, and wherein the first and second L1-localized trait of interest is selected from the group consisting of biotic stress resistance, abiotic stress resistance, improved seed germination, fruit color and the ability to accept pollen produced by the second plant or by the plant itself.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claims 16-26 are product by process claims.
The method steps (a), (b), (c) and (d) of the reference claim 1 are the same as the method steps (a), (b), (c) and (d) of instant claim 16, subject matter wise and language wise.
Reference dependent claims 2-12 recite essentially the same limitations as instant dependent claims 17-26.
Thus, instant claims 16-26 are obvious resultant products produced by the reference method.
Regarding instant claims 27-35, the claims recite a periclinal chimeric plant comprising traits in the L1, L2 and/or L3 layers.
The method steps (a), (b), (c) and (d) of the reference claim 1 produce the same periclinal chimeric plant comprising traits in the L1, L2 and/or L3 layers recited in instant claim 27. Reference claim 1 recites making a periclinal chimera plant that “the first and second L1-localized trait of interest is selected from the group consisting of biotic stress resistance, abiotic stress resistance, improved seed germination, fruit color and the ability to accept pollen produced by the second plant or by the plant itself”, the recited trait(s) is/are the same as instant claim 27 (in last wherein clause).
Reference dependent claims 2-12 recite essentially the same limitations as instant dependent claims 28-35.
Thus, instant claims 27-35 are obvious resultant products produced by the reference method.
Therefore, the claims are obvious over each other.
Please note that the 35 U.S.C. 121 prohibition applies only where the Office has made a requirement for restriction. The U.S. Court of Appeals for the Federal Circuit has concluded that the protection of 35 U.S.C. 121 does not extend to all types of continuing applications, stating that "the protection afforded by section 121 to applications (or patents issued therefrom) filed as a result of a restriction requirement is limited to divisional applications." Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353, 1362, 86 USPQ2d 1001, 1007-1008 (Fed. Cir. 2008).
In this case, (1) claim 12 reciting “A periclinal chimera plant obtained by the method according to claim 1, or a plant vegetatively derived thereof” of the parent application 16449329/US Patent 11950553 was not restricted by examiner (examined, see claim sets from 10/31/2019 to 10/19/2023), and (2) instant application is a CON of 16449329. Thus, the double patenting rejection is proper.
Remarks
For compact prosecution, the following references are relevant to instant application, thus are filed but not cited by the examiner:
Togami et al (US 8183434, granted and published 5/22/2012; filed 3/28/2008).
Pelsy et al (Chromosome Replacement and Deletion Lead to Clonal Polymorphism of Berry Color in Grapevine. PLOS Genetics, p1-18, 2015).
University of Florida (Report of the Tomato Genetics Cooperative Number 56, 2006).
Conclusion
No claim is allowed.
Contact information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WAYNE ZHONG whose telephone number is (571)270-0311. The examiner can normally be reached 8:30am to 5:00pm EST.
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/Wayne Zhong/
Primary Examiner, Art Unit 1662